Trial · NCT01024036

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

NCT01024036, Phase 2, Completed, Janssen Research & Development, LLC; results first posted 2014-08-20

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease. Trials, record NCT01024036. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01024036

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
NCT number: NCT01024036
Status: Completed
Phases: Phase 2
Enrollment: 79 participants, actual
Lead sponsor: Janssen Research & Development, LLC
Conditions: Multicentric Castleman's Disease
Interventions: Siltuximab, Placebo, Best Supportive Care (BSC)
First posted: 2009-12-02
Last updated: 2018-03-21
Other registries' IDs: eudract:2009-012380-34
Results first posted: 2014-08-20

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review	From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier	Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care \[BSC\] minus Placebo+BSC).
Secondary	Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review	From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years)	Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. Symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: \>=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.
Secondary	Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review	From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)	Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a \>=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care \[BSC\] minus Placebo+BSC).
Secondary	Median Duration of Tumor Response - by Independent Radiology Review	From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)	Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a \>=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care \[BSC\] minus Placebo+BSC).
Secondary	Time to Treatment Failure	From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier	Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms \>=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman's disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC).
Secondary	Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)	Week 13	Hemoglobin response rate is defined as percentage of participants who achieved \>= 15 g/L hemoglobin at Week 13.
Secondary	Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)	Week 13	Hemoglobin response rate is defined as percentage of participants who achieved \>= 20 g/L hemoglobin at Week 13.
Secondary	Percentage of Participants Who Discontinued Corticosteroids	From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years)	Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1).
Secondary	6-year Survival Rate	until 6 years	Overall survival was defined as percent chance of survival of participants who were still alive at 6 years from time of first study treatment was analyzed.
Secondary	Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline	From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)	A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe).

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review	From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier	Intent-to-treat (ITT) population: all randomized participants.	Percentage of participants	NUMBER
SECONDARY	Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review	From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years)	All randomized participants who achieved durable tumor and symptomatic response during blinded treatment period as per independent review.	Days	MEDIAN
SECONDARY	Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review	From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)	Response-evaluable Population: included participants who received at least 1 administration of siltuximab/placebo and had at least 1 post-baseline radiologic disease evaluation.	Percentage of participants	NUMBER
SECONDARY	Median Duration of Tumor Response - by Independent Radiology Review	From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)	All randomized participants who achieved tumor response during blinded treatment period as per independent review.	Days	MEDIAN
SECONDARY	Time to Treatment Failure	From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier	Intent-to-treat (ITT) population: all randomized participants.	Days	MEDIAN
SECONDARY	Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)	Week 13	Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 postbaseline hemoglobin evaluation.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)	Week 13	Hemoglobin response-evaluable population: participants who received at least 1 siltuximab/placebo administration and have a baseline hemoglobin that is below the lower limit of normal as per local laboratory specifications (within 2 weeks before starting treatment) and at least 1 post-baseline hemoglobin evaluation.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Discontinued Corticosteroids	From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years)	All randomized participants who were dependent on corticosteroids at baseline.	Percentage of participants	NUMBER
SECONDARY	6-year Survival Rate	until 6 years	Safety Analysis set included all randomized participants who received at least 1 dose of study agent.	Percent chance of survival	MEDIAN
SECONDARY	Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline	From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)	Intent-to-treat (ITT) population: all randomized participants.	Days	MEDIAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group23

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review	Placebo + Best Supportive Care (BSC)	0		Percentage of participants
Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review	Siltuximab + Best Supportive Care (BSC)	34		Percentage of participants
Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review	Siltuximab + Best Supportive Care (BSC)	383.0	Full Range 232 to 676	Days
Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review	Placebo + Best Supportive Care (BSC)	3.8		Percentage of participants
Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review	Siltuximab + Best Supportive Care (BSC)	37.7		Percentage of participants
Median Duration of Tumor Response - by Independent Radiology Review	Placebo + Best Supportive Care (BSC)	70	Full Range 70 to 70	Days
Median Duration of Tumor Response - by Independent Radiology Review	Siltuximab + Best Supportive Care (BSC)	356	Full Range 55 to 674	Days
Time to Treatment Failure	Placebo + Best Supportive Care (BSC)	134	95% Confidence Interval 85 to NA	Days
Time to Treatment Failure	Siltuximab + Best Supportive Care (BSC)	NA	95% Confidence Interval 378 to NA	Days
Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)	Placebo + Best Supportive Care (BSC)	0		Percentage of participants

1 to 10 of 23Source ClinicalTrials.gov

See all 23 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Blinded Treatment	STARTED	Siltuximab + Best Supportive Care (BSC)	53
Blinded Treatment	STARTED	Placebo + Best Supportive Care (BSC)	26
Blinded Treatment	COMPLETED	Siltuximab + Best Supportive Care (BSC)	31
Blinded Treatment	COMPLETED	Placebo + Best Supportive Care (BSC)	6
Blinded Treatment	NOT COMPLETED	Siltuximab + Best Supportive Care (BSC)	22
Blinded Treatment	NOT COMPLETED	Placebo + Best Supportive Care (BSC)	20
Unblinded Treatment	STARTED	Siltuximab + Best Supportive Care (BSC)	0
Unblinded Treatment	STARTED	Placebo + Best Supportive Care (BSC)	13
Unblinded Treatment	COMPLETED	Siltuximab + Best Supportive Care (BSC)	0
Unblinded Treatment	COMPLETED	Placebo + Best Supportive Care (BSC)	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events995

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Placebo + Best Supportive Care (BSC) (Blinded)	5	26
other	Anaemia	Blood and lymphatic system disorders	Siltuximab + Best Supportive Care (BSC) (Blinded)	5	53
other	Anaemia	Blood and lymphatic system disorders	Siltuximab + Best Supportive Care (BSC) (Unblinded)	4	13
other	Anaemia	Blood and lymphatic system disorders	Placebo + BSC (Follow-up Period)	2	6
other	Anaemia	Blood and lymphatic system disorders	Siltuximab + BSC (Follow-up Period)	2	14
other	Leukopenia	Blood and lymphatic system disorders	Placebo + Best Supportive Care (BSC) (Blinded)	2	26
other	Leukopenia	Blood and lymphatic system disorders	Siltuximab + Best Supportive Care (BSC) (Blinded)	3	53
other	Leukopenia	Blood and lymphatic system disorders	Siltuximab + Best Supportive Care (BSC) (Unblinded)	1	13
other	Leukopenia	Blood and lymphatic system disorders	Placebo + BSC (Follow-up Period)	2	6
other	Leukopenia	Blood and lymphatic system disorders	Siltuximab + BSC (Follow-up Period)	1	14

1 to 10 of 995Source ClinicalTrials.gov

See all 995 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo + Best Supportive Care (BSC) (Blinded)
Total, all-cause mortality	Siltuximab + Best Supportive Care (BSC) (Blinded)
Total, all-cause mortality	Siltuximab + Best Supportive Care (BSC) (Unblinded)
Total, all-cause mortality	Placebo + BSC (Follow-up Period)
Total, all-cause mortality	Siltuximab + BSC (Follow-up Period)
Total, other adverse events	Placebo + Best Supportive Care (BSC) (Blinded)	25	26
Total, other adverse events	Siltuximab + Best Supportive Care (BSC) (Blinded)	53	53
Total, other adverse events	Siltuximab + Best Supportive Care (BSC) (Unblinded)	13	13
Total, other adverse events	Placebo + BSC (Follow-up Period)	5	6
Total, other adverse events	Siltuximab + BSC (Follow-up Period)	14	14

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25042199	DERIVED	PubMed
28087540	DERIVED	PubMed
35793409	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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The record and each of its lists are JSON, twenty rows a page. No key.

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